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A Phase II Study to Evaluate the Efficacy and Safety of FB825 in Adult Patients With Moderate-to-severe Allergic Asthma
Led by Oneness Biotech Co., Ltd. · Updated on 2026-01-12
100
Participants Needed
13
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oneness Biotech Co., Ltd.
Lead Sponsor
M
Microbio Shanghai Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a drug called FB825 in adults with moderate-to-severe allergic asthma. This randomized, placebo-controlled, and double-blind Phase II study aims to compare FB825 with a placebo to better understand its impact on asthma exacerbations and lung function. The study is sponsored by Oneness Biotech Co., Ltd. and involves patients who have been diagnosed with allergic asthma for at least one year. The study includes a 4-week screening period, followed by a 24-week treatment phase and a 12-week follow-up period. Participants will be randomly assigned to receive either FB825 or placebo in equal numbers. The treatment involves an initial intravenous infusion of 8 mg/kg followed by five infusions of 4 mg/kg every four weeks. Patients will continue their usual asthma control medications, such as inhaled corticosteroids and long-acting beta-agonists, during the study. After the treatment phase, participants will return to combination therapy with inhaled corticosteroids and beta-agonists as needed. During the trial, patients will undergo regular assessments including lung function tests, asthma control questionnaires, and monitoring for any asthma exacerbations. Researchers will also track adverse events to evaluate safety. The main outcome measured is the occurrence of asthma exacerbations at 24 weeks after starting treatment. Additional evaluations include changes in lung function and symptom control throughout the study. The total participation duration is approximately 40 weeks, including screening, treatment, and follow-up.
CONDITIONS
Brief Title
Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Diagnosed with moderate-to-severe allergic asthma for at least 12 months
- Documented reversibility or airway hyperresponsiveness as defined in study criteria
- Pre-bronchodilator FEV1 between 40% and 80% predicted within 2 months before randomization
- On medium- or high-dose inhaled corticosteroids plus long-acting beta-agonist for at least 3 months with stable dose for 30 days before screening
- History of at least one asthma exacerbation in the past 12 months
- Total serum IgE level of at least 125 IU/mL
- Positive skin prick test or allergen-specific IgE above normal range
- Uncontrolled asthma with ACQ-5 score of 1.5 or higher during screening and randomization
- Completed respiratory infection treatment at least 4 weeks before screening
- Female subjects of childbearing potential must use two forms of birth control and have a negative pregnancy test
- Body weight of at least 40 kg
- Normal or non-significant abnormal ECG
- Able to provide written informed consent and comply with study requirements
You will not qualify if you...
- Asthma exacerbation requiring systemic steroids within 30 days before randomization
- More than 20% change in post-bronchodilator FEV1 between screening and randomization
- Pregnant or lactating females
- Positive HIV test or use of antiretroviral medications
- Active hepatitis B or C infection
- Active lung diseases other than allergic asthma
- Use of experimental drugs within 30 days or 5 half-lives before screening
- Treatment with certain monoclonal antibodies or anti-IgE antibodies within 6 months before screening
- History of alcohol or drug abuse impairing study participation
- Conditions compromising study safety or participation
- Severe liver or kidney disease as defined by study criteria
- Immunosuppression or immunodeficiency
- Active or latent tuberculosis
- History of malignancy within 5 years except certain skin or cervical cancers
- Current smokers with over 10 pack-years or use of nicotine products
- High risk or evidence of parasitic infection
- Recent live or COVID-19 vaccinations as specified
- History of serious arrhythmias or respiratory failure
- History of anaphylaxis to biologics
- Major surgery within 8 weeks before screening
- Comorbid diseases interfering with study procedures
- Use of non-selective beta blockers or recent dose changes of selective beta-1 blockers
- Bronchial thermoplasty within 3 years or planned during study
- Active autoimmune disease or high-risk autoantibody status
- Use of prohibited traditional Chinese medications within 3 months
- Uncontrolled aggravating factors like gastroesophageal reflux
- Adrenal insufficiency confirmed by testing
- Recent COVID-19 infection within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants provide informed consent and undergo eligibility assessments during this period.
Duration - 24 weeks
Participants receive either FB825 or placebo through intravenous infusion while maintaining background asthma therapy, followed by a tapering phase and then FB825 monotherapy.
6 visits for dosing: 1 initial dose and 5 subsequent doses every 4 weeks; additional visits for assessments at weeks 12, 16, and 24.
Duration - 12 weeks
Participants are monitored after treatment while returning to ICS/LABA combination therapy and using rescue medication as needed.
Visits occur to monitor safety and asthma control after treatment ends.
Trial Site Locations
Total: 13 locations
1
Kaohsiung Chang Gung Medical Foundation
Kaohsiung City, Taiwan
Actively Recruiting
2
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
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3
Far Eastern Memorial Hospital
New Taipei City, Taiwan
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4
China Medical University Hospital
Taichung, Taiwan
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5
Taichung Venterans General Hospital
Taichung, Taiwan
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6
National Cheng Kung University Hospital
Tainan, Taiwan
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7
Linkou Chang Gung Memorial Hospital
Taipei, Taiwan
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8
MacKay Memorial Hospital
Taipei, Taiwan
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9
Ministry of Health and Welfare Shuang-Ho Hospital
Taipei, Taiwan
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10
National Taiwan University Hospital
Taipei, Taiwan
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11
Taipei Medical University Hospital
Taipei, Taiwan
Actively Recruiting
12
Taipei Municipal Wanfang Hospital
Taipei, Taiwan
Actively Recruiting
13
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
J
June Kuo
P
Pei-Jin Ho
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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